Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals Inc (GPI) has received approval for its Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (US FDA) for Vigabatrin for Oral Solution USP, 500 mg. It is bioequivalent to the reference listed drug product (RLD), Sabril (vigabatrin) for Oral Solution, 500 mg, of Lundbeck Pharmaceuticals LLC.
Vigabatrin for Oral Solution (brand and generic) products had U.S. sales of approximately $255 million MAT for the most recent twelve months ending in February 2020 according to IQVIA Health. Granules now has a total of 27 ANDA approvals from US FDA (25 Final approvals and 2 tentative approvals).
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
